(25 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial: Urology (including prostate): Transesophageal (TE): Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neurological).
The GE LOGIQ P6 is full-featured, general-purpose diagnostic ultrasound system consisting of a mobile console approximately 49 cm wide, 64 cm deep and 135-141 cm high that provide digital acquisition, processing and display capability. The user interface includes a computer keyboard. specialized controls and color video LCD display. The modification combines features of the unmodified system with additional features from other systems currently marketed by GE Healthcare to provide users with improved imaging capability and acoustic control.
The provided text describes a Special 510(k) Premarket Notification for the GE LOGIQ P6 Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than on proving performance against specific acceptance criteria for a new medical indication through clinical trials.
Therefore, the document explicitly states "Clinical Tests: None required." This means a study proving the device meets acceptance criteria as typically understood for new clinical claims was not performed or deemed necessary for this submission. The substantial equivalence argument relies on the device being comparable to an existing, legally marketed device (GE LOGIQ P5 Diagnostic Ultrasound System).
Here's an analysis based on the information provided, specifically addressing why certain criteria cannot be met:
Acceptance Criteria and Device Performance
Since no clinical tests demonstrating performance against specific acceptance criteria were required or conducted for this 510(k) submission, a table of acceptance criteria and reported device performance cannot be generated from the provided text. The submission focuses on demonstrating "substantial equivalence" based on technological characteristics and intended uses, rather than empirical performance metrics for a novel clinical claim.
Study Information (Based on provided document)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No clinical test set was used, as "Clinical Tests: None required." The device's safety and effectiveness were established by comparison to a predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No test set requiring expert ground truth was established, as "Clinical Tests: None required."
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring an adjudication method was used, as "Clinical Tests: None required."
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC comparative effectiveness study was not done. The device is a diagnostic ultrasound system, not an AI-based interpretation tool that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The GE LOGIQ P6 is a diagnostic ultrasound system operated by a qualified physician, not a standalone algorithm. Its performance is inherent to its image acquisition and processing capabilities.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth for clinical performance was established, as "Clinical Tests: None required." The ground for substantial equivalence is the safety and effectiveness of the predicate device (GE LOGIQ P5).
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The sample size for the training set:
- Not applicable. This document pertains to regulatory clearance for an ultrasound system, not the development or training of an AI algorithm. Therefore, there is no mention of a "training set" in the context of machine learning.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI algorithm is referenced in this regulatory document.
In summary: The GE LOGIQ P6 Ultrasound System gained market clearance through a Special 510(k) pathway by demonstrating substantial equivalence to a predicate device (GE LOGIQ P5). This pathway does not typically require new clinical studies to establish individual performance metrics against acceptance criteria for novel clinical claims. Instead, it relies on the established safety and effectiveness of the predicate device and the new device's comparable technological characteristics and intended uses. The document explicitly states "Clinical Tests: None required."
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.